Zoll M SpO2 User manual

Pulse Oximetry (SpO2)

9650-0202-01 Rev. J
This issue date or revision level for this operation guide is shown on the front cover. ZOLL and M Series are trademarks of ZOLL Medical Corporat ion.
© 2002 by ZOLL Medical Corporation. All rights reserved
PULSE OXIMETRY (SpO2)

General Information

Product Description
The M Series Pulse Oximeter (SpO2) continuously and non-invasively measures the oxygen saturation of arteriolar hemoglobin at a peripheral measurement sit e , (i.e. foot, toe or finger). It is used for monitoring patients who are at risk of developing hypoxemia. SpO details of oxygen transportation in the body. It is widely used because it is non-invasive, continuous, easily applied and painless.
The oximetry sensor contains two light emitting diodes (LEDs) that transmit red and infrared light through the body’s extremities. The transmitted light is then received by a photodetector.
Oxygen-saturated blood absorbs light differently than unsaturated blood. Thus the amount of red and infrared light absorbed by blood flowing through a suitable peripheral area of the body, typically the finger in adults and the foot in neonates, can be used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arteria l blood. The monitor displays this ratio as percent SpO
The quality of SpO
. Normal values typically range from 95% to 100% at sea level.
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measurements depends on correct application and size of the sensor, adequate blood flow through the
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sensor site, and exposure to ambient light. For correct placement and location of the sensors refer to the Directions for Use contained on all LNOP
monitoring gives information about both the cardiac and respiratory systems, and provides
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oximetry sensor packages.
How to Use This Manual
This section explains how to set up and use the M Series Pulse Oximeter. Important safety information relating to general use of the M Series Pulse Oximeter appears in the “Safety Considerations” section of this manual. Other important safety information is located in the “Safety Considerations” section of the LNOP
The M Series Operator's Guide provides information operators need for the safe and effective use and care of the
M Series products. It is important that persons using this device read and understand all the information contained within. Please thoroughly read both safety considerations and warnings sections before operating your
M Series product.
SpO2 Accessories
LNOP
LNOP
LNOP
LNOP
LNOP
PC04 : 4’ Reusable Patient Cable
PC08 : 8’ Reusable Patient Cable
PC12 : 12’ Reusable Patient Cable
- Adt : Single use sensor for patients > 30kg
- Pdt : Single use sensor for Pediatrics and Slender Adults >10kg and < 50kg
- Neo : Single use sensor for Neonates < 10kg
- Neo Pt : Single use sensor for Neonates < 1kg (Pre - Term)
- DC1 : Reusable sensor for Adults and Pediatrics > 30kg
* Masimo SET and LNOP are registered trademarks of Masimo Corporation.
oximetry sensor packages.
9650-0202-01 SpO2 - 1 Rev. J
OPTION INSER T
SpO2 Intended Use
The ZOLL M Series Pulse Oximeter with Masimo SET technology and the LNOP for the continuous noninvasive monitoring of arterial oxygen saturation (SpO
) and pulse rate during both no motion and
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patient motion conditions for adult patients, and no motion conditions for pediatric and neonatal patients, i n a hospital and pre-hospital environment.
Oxygen saturation measurements using pulse oximetry are highly dependent on proper placement of the sensor and patient conditions. Patient conditions such as smoke inhalation may result in erroneous oxygen saturation readings. If pulse oximetry measurements are suspect, verify the reading using another clinically accepted measurement method, such as arterial blood gas measurements.
The M Series Pulse Oximetry option is intended for use only with ZOLL / Masimo LNOP
Series of Sensors are indicated
sensors.
Measurement Complications
There is arterial occlusion prox imal to the sensor.
The patient is in cardiac arrest or shock.
SpO2 Connector and Sensors
The SpO2 connector is located on the rear panel of the M Series unit. Only ZOLL or Masimo accessories and sensors can be used with the M Series Pulse Oximetry option.
Each sensor is designed for application to a specific anatomical site on patients within a certain weight range. To ensure optimal performance, use an appropriate sensor, apply it as described in the sensor's Directions for Use, keep the sensor at the lev el of the patient's heart, and always observe all warnings and cautions.
Tissue damage can result from incorrect application or use of a sensor (e.g., wrapping the sensor too tightly, applying supplemental tape, failing to periodically inspect the sensor site). Refer to the Directions for Use provided with each sensor for specific instructions on application and use.
If the accuracy of any reading is suspect, first check the patient's vital signs by alternate means and then check the M Series Pulse Oximeter for pr oper functioning.
Inaccurate measurements may be caused by:
Incorrect sensor application or use.
Significant levels of dysfunctional hemoglobins
(e.g., carboxyhemoglobin or methemoglobin).
Intravascular dyes such as indocyanine green or methylene blue.
Exposure to excessive illumination, such as surgical lamps (especially those with a xenon light source), bilirubin lamp s , fluoresc en t lights, infrared heating lamps, or direct sunlight. Exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material.
Excessive patient movement .
Venous pulsations.
Placement of a sensor on an extremity with a blood
pressure cuff, arterial catheter, or intravascular line.
Loss of pulse signal can occur under any of the following situations:
The sensor is applied too tightly.
There is excessive illumination from light sources such
as a surgical lamp, a bilirubin lamp, or sunlight.
A blood pressure cuff is inflated on the same extremity as the one with a SpO
sensor attached.
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Excessive patient movement.
The patient has hypotension, severe vasoconstriction,
or hypothermia.
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SAFETY CONSIDERATIONS
Warnings
General
Before use, carefully read the M Series Operator’s Guide, these operating instructions, and the ZOLL / Masimo LNOP
The M Series pulse oximeter is to be operated by
qualified personnel only.
A pulse oximeter should NOT be used as an apnea
monitor.
Do not immerse the M Series device, patient cables
or sensors in water, solvents, or cleaning solutions. A pulse oximeter should be considered an early
warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient's condition.
If an alarm occurs while the alarms are suspended, the suspended alarm indications will only be visual displays and symbols.
To ensure patient safety, the ECG-out jack and modem (if available) should only be connected to other equipment with galvanically isolated circuits.
Interfering Substances: Carboxyhemoglobin and methemoglobin may erroneously alter SpO readings. The level of change is approximately equal to the amount of carboxyhem oglobin or methemoglobin present. Dyes, or any substance containing dyes, that alter arterial pigmentation may cause erroneous readings.
Do not use the M Series pulse oximeter or LNOP sensors during magnetic resonance imaging (MRI). Induced current could potentially cause burns. The M Series pulse oximeter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulat ion.
Use ONLY the line cord supplied by ZOLL Medical Corporation for continued safety and EMI performance.
Sensor directions for use.
PULSE OXIMETRY
Sensors
Tissue damage can result from incorrect application
Do not use damaged LNOP sensors or cables.
Do not use an LNOP sensor with exposed optical
Do not sterilize the sensor by irradiation, steam, or
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Use only ZOLL / Masimo LNOP Oximetry Sensors for SpO sensors may cause improper oximeter performance.
or use of an LNOP the sensor too tightly. Inspect the sensor site as directed in the sensors’ Directions for Use to ensure skin integrity, correct positioning and adhesion of the sensor.
components.
ethylene oxide. See the cleaning instructions in the Directions for Use for reusable Masimo LNOP sensors.
Do not allow the sensor to remain on one site for a prolonged period of time, especially when monitoring neonates. Check the application site at regular intervals - at least every two hours - and change the site if any compromise in skin quality should occur. Refer to the sensor’s specific directions for use.
Do not attach the SpO2 sensor to a limb being monitored with a blood pressure cuff or limb with restricted blood flow.
A poorly applied sensor may give incorrect saturation values. The signal strength indicator can be used to identify a poorly applied sensor or poorly chose n si te .
Choose a site with sufficient perfusion to ensure accurate oximetry values.
Certain nail aberrations, nail polish, fungus, etc. may cause inaccurate oximetry readings. Remove the nail polish and/or move the sensor to an unaffected digit.
Before use, carefully read the SpO2 Sensor directions for use.
High ambient light sources such as surgical lights (especially those with xenon light source), bilir ubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight can affect the accuracy of S pO readings.
measurements. Other manufacturers’
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sensor, for example by wrapping
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